Topline
The Food and Drug Administration is reviewing a flu vaccine that people could administer themselves at home, British drugmaker AstraZeneca said on Tuesday, potentially the first product of its kind that could boost accessibility, increase uptake and offer an alternative for people scared of needles.
Key Facts
The FDA has said it will review AstraZeneca’s nasal spray flu vaccine, marketed as FluMist Quadrivalent, to allow people over the age of 18 to self-administer or administer it to eligible patients ages 2 to 49 years, the British pharma company said in a statement.
FluMist was first approved in the U.S. in 2003 and is the only nasal spray flu vaccine authorized in the country.
AstraZeneca said its request to market the vaccine for self-administration and for other groups is supported by a “usability study” demonstrating that people can do so properly without needing supervision from a healthcare worker, as well as “extensive data” showing it is comparable to other shots in terms of safety and effectiveness.
The company said it expects the FDA to make a decision on the vaccine in the first three months of 2024.
If approved, it will be the first self-administered flu vaccine to be authorized and AstraZeneca said it should be available for self-administration for the 2024–25 flu season.
Iskra Reic, executive vice president for AstraZeneca’s vaccines and immune therapies division, said a green light for self-administration for FluMist “could revolutionize flu vaccination,” adding that the company hopes it could “be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities.”
Key Background
A new form of vaccine that can be posted to people for them to take themselves or give to others would be a victory in efforts to make vaccines more accessible. This is especially so for a vaccine that does not require a needle, something as many as two in three children and one in four adults are afraid of, according to the Centers for Disease Control and Prevention. Health officials hope more options will boost lackluster vaccination rates. The flu, caused by a number of influenza viruses, is a contagious and potentially severe infection that many experts caution Americans to underestimate at their peril. Every year, the CDC estimates the seasonal flu sickens an estimated 9 million to 41 million people, hospitalizes 140,000 to 710,000 and kills 12,000 to 52,000. Annually, this costs the U.S. around $10.4 billion in direct costs for hospitalizations and outpatient visits for adults alone, the agency said. In addition to seasonal variants, influenza is well known to be able to trigger lethal pandemics that can kill tens of millions of people around the world and experts widely believe it is only a matter of time before the next flu pandemic rears its ruthless head.
Tangent
AstraZeneca’s head of U.S. medical affairs Lisa Glasser told CNN patients will still be able to receive FluMist at the doctor’s office or pharmacy as now but that they could also go through an online pharmacy system to have it sent to their home for them to administer themselves. The system will be designed in a way to ensure the vaccine is only used by people for whom it is suitable, Glasser said, and shipped in temperature-controlled packaging to ensure storage conditions are maintained. Glasser said the widespread use of nasal tests during the Covid-19 pandemic showed that “people can do things for themselves” and that “they can take maybe more responsibility for their own healthcare in their own hands than perhaps we realized or even thought possible.” As the vaccine uses a live virus that has been modified so that it can provoke an immune response but not cause illness, it is not suitable for people with compromised immune systems.
Big Number
200 million. That’s how many doses of FluMist have been distributed around the world since it was first approved in the U.S. in 2003, AstraZeneca said.
The Flu Vaccine Works—In a Way Most People Don’t Appreciate (Scientific American)
Vaccine fatigue is leaving the US vulnerable to flu (CNN)
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